What Is the Prevalence of Intimate Partner Violence and Traumatic Brain Injury in Fracture Clinic Patients?

BACKGROUND: Individuals in violent intimate relationships are at a high risk of sustaining both orthopaedic fractures and traumatic brain injury (TBI), and the fracture clinic may be the first place that concurrent intimate partner violence (IPV) and TBI are recognized. Both IPV and TBI can affect all aspects of fracture management, but prevalence of TBI and comorbid TBI and IPV is unknown. QUESTIONS/PURPOSES: (1) What are the previous-year and lifetime prevalence of IPV and TBI in women presenting to an outpatient orthopaedic fracture clinic? (2) What are the conditional probabilities of TBI in the presence of IPV and the reverse, to explore whether screening for one condition could effectively identify patients with the other? (3) Do patients with TBI, IPV, or both have worse neurobehavioral symptoms than patients without TBI and IPV? METHODS: The study was completed in the fracture clinic at a community Level 1 trauma center in Southern Ontario from July 2018 to March 2019 and included patients seen by three orthopaedic surgeons. Inclusion criteria were self-identification as a woman, age 18 years or older, and the ability to complete forms in English without assistance from the person who brought them to the clinic (for participant safety and privacy). We invited 263 women to participate: 22 were ineligible (for example, they were patients of a surgeon who was not on the study protocol), 87 declined before hearing the topic of the study, and data from eight were excluded because the data were incomplete or lost. Complete data were obtained from 146 participants. Participants' mean age was 52 ± 16 years, and the most common diagnosis was upper or lower limb fracture. Prevalence of IPV was calculated as the number of women who answered "sometimes" or "often" to direct questions from the Woman Abuse Screening Tool, which asks about physical, emotional, and sexual abuse in the past year or person's lifetime. The prevalence of TBI was calculated as the number of women who reported at least one head or neck injury that resulted in feeling dazed or confused or in loss of consciousness lasting 30 minutes or less on the Ohio State University Traumatic Brain Injury Identification Method, a standardized procedure for eliciting lifetime history of TBI through a 3- to 5-minute structured interview. Conditional probabilities were calculated using a Bayesian analysis. Neurobehavioral symptoms were characterized using the Neurobehavioral Symptom Inventory, a standard self-report measure of everyday emotional, somatic, and cognitive complaints after TBI, with total scores compared across groups using a one-way ANOVA. RESULTS: Previous-year prevalence of physical IPV was 7% (10 of 146), and lifetime prevalence was 28% (41 of 146). Previous-year prevalence of TBI was 8% (12 of 146), and lifetime prevalence was 49% (72 of 146). The probability of TBI in the presence of IPV was 0.77, and probability of IPV in the presence of TBI was 0.36. Thus, screening for IPV identified proportionately more patients with TBI than screening for TBI, but the reverse was not true. Neurobehavioral Symptom Inventory scores were higher (more symptoms) in patients with TBI only (23 ± 16) than those with fractures only (12 ± 11, mean difference 11 [95% CI 8 to 18]; p < 0.001), in those with IPV only (17 ± 11) versus fractures only (mean difference 5 [95% CI -1 to -11]; p < 0.05), and in those with both TBI and IPV (25 ± 14) than with fractures only (mean difference 13 [95% CI 8 to 18]; p < 0.001) or those with IPV alone (17 ± 11, mean difference 8 [95% CI -1 to 16]; p < 0.05). CONCLUSION: Using a brief screening interview, we identified a high self-reported prevalence of TBI and IPV alone, consistent with previous studies, and a novel finding of high comorbidity of IPV and TBI. Given that the fracture clinic may be the first healthcare contact for women with IPV and TBI, especially mild TBI associated with IPV, we recommend educating frontline staff on how to identify IPV and TBI as well as implementing brief screening and referral and universal design modifications that support effective, efficient, and accurate communication patients with TBI-related cognitive and communication challenges. LEVEL OF EVIDENCE: Level II, prognostic study.

Prevalence and Perception of Intimate Partner Violence-Related Traumatic Brain Injury.

BACKGROUND: Traumatic brain injury (TBI) is a serious and often undiagnosed consequence of intimate partner violence (IPV). Data on prevalence of TBI among IPV survivors are emerging, but prevalence of IPV among patients presenting to TBI clinics is unknown. Identification of IPV is important to ensure patients with TBI receive appropriate intervention and referrals. OBJECTIVE: To determine the proportion of women 18 years and older presenting to an acquired brain injury (ABI) clinic with confirmed or suspected concussion who reported experiencing IPV in the last 12 months or their lifetime. METHODS: Single-center cross-sectional cohort study. Proportion of IPV-related TBI or head, neck, or facial) injuries were determined using a modified HELPS Brain Injury Screening Tool and the Neurobehavioral Symptom Inventory. RESULTS: Of the 97 women approached, 50 were enrolled in the study. The average age was 46.1 years and 32 women (64.0%) reported a relationship history with a violent partner; 12-month prevalence of IPV was 26.5% and lifetime prevalence was 44.0%. Within their lifetime, all (44.0%) who reported an IPV history reported emotional abuse, 24.0% reported physical abuse, and 18.0% sexual abuse. HELPS responses indicated a high potential of lifetime IPV-related TBI for 29.2%, most commonly from being hit in the face or head (20.8%). CONCLUSION: Implementation of IPV screening in community-based ABI clinics is a pivotal step toward understanding the potential scope of TBI and addressing the wide range of somatic, cognitive, and affective symptoms experienced by IPV survivors. IPV screening also will lead to timely referral and follow-up and increase patient safety after discharge from rehabilitation.

"It's about getting the best bang for your buck": Exploring local councils' perceptions about providing exercise infrastructure in public parks.

ISSUE ADDRESSED: Growing evidence suggests that public parks enable physically active communities; however, little is known of the impact of council-provided exercise facilities in outdoor green spaces, and the challenges of providing this infrastructure at a local level. This paper sought to describe some of the factors, as perceived by local government area (LGA) council representatives within Queensland, Australia, that influence community use of, as well as council provision for, weight-bearing outdoor fitness station infrastructure in public parks. METHODS: A nested mixed-methods study was employed, comprised of a survey sent to council representatives for all 78 Queensland LGAs (Stage 1), and follow-up interviews to elicit further insights into the provision of infrastructure in public parks (Stage 2; n = 7). Perceptions around participants' corporate role in the provision of outdoor fitness stations were the focus of analyses. FINDINGS: A thematic analysis described themes of: Moderating public attitudes and motivation; The flow of information; Supporting an active community; Return on investment; and Safety, complianceand climate. Provision of equipment was influenced by the perception that it represented poor value for money, in terms of the desired outcome of increased physical activity, especially when compared with other types of infrastructure (particularly, walking trails); however, opinions about this lack of use outdoor exercise equipment were most often based on anecdotal evidence. CONCLUSIONS: Councils are motivated to support active communities. They would benefit from better access to information about park usage, strategies for marketing healthy living initiatives and data about the economic benefits of parks. SO WHAT?: The current study explores the perspectives of LGA professional "gatekeepers," who develop and maintain public physical activity facilities. Their insights are essential to better understand the practicalities of delivering desirable urban green spaces for physically active communities.

A scoping review of intimate partner violence educational programs for health care professionals.

Multiple intimate partner violence (IPV) educational programs have been developed for health care professionals (HCPs); however, program content and effectiveness vary substantially. The purpose of this scoping review was to identify and synthesize the literature evaluating IPV education programs for HCPs to identify key areas for potential evidence-based recommendations and focus future research priorities. We conducted a systematic literature search using broad eligibility criteria to identify studies published between January 2000 and July 2015 that evaluated the effectiveness of IPV education programs in health care settings. All potentially eligible references were screened independently by two reviewers. Data extraction was completed independently by two reviewers for all eligible studies. Descriptive statistics were used to summarize all data. We identified 65 eligible studies, 55% of which reported positive program effectiveness. Effective programs often reported the use of online training components, delivery by an IPV educator/expert or physician/surgeon, the inclusion of a treatment protocol and resources for patients and HCPs, and included more than five training sessions lasting no more than one hours each. Our results demonstrate that IPV educational programs are heterogeneous and that a wide variety of methodologies have been used to evaluate their effectiveness.

A scoping review of the proximal humerus fracture literature.

BACKGROUND: Proximal humerus fractures are a common fragility fracture that significantly affects the independence of older adults. The outcomes of these fractures are frequently disappointing and previous systematic reviews are unable to guide clinical practice. Through an integrated knowledge user collaboration, we sought to map the breadth of literature available to guide the management of proximal humerus fractures. METHODS: We utilized a scoping review technique because of its novel ability to map research activity and identify knowledge gaps in fields with diverse treatments. Through multiple electronic database searches, we identified a comprehensive body of proximal humerus fracture literature that was classified into eight research themes. Meta-data from each study were abstracted and descriptive statistics were used to summarize the results. RESULTS: 1,051 studies met our inclusion criteria with the majority of research being performed in Europe (64%). The included literature consists primarily of surgical treatment studies (67%) and biomechanical fracture models (10%). Nearly half of all clinical studies are uncontrolled case series of a single treatment (48%). Non-randomized comparative studies represented 12% of the literature and only 3% of the studies were randomized controlled trials. Finally, studies with a primary outcome examining the effectiveness of non-operative treatment or using a prognostic study design were also uncommon (4% and 6%, respectively). CONCLUSIONS: The current study provides a comprehensive summary of the existing proximal humerus fracture literature using a thematic framework developed by a multi-disciplinary collaboration. Several knowledge gaps have been identified and have generated a roadmap for future research priorities.

A scoping review of biomechanical testing for proximal humerus fracture implants.

BACKGROUND: Fixation failure is a relatively common sequela of surgical management of proximal humerus fractures (PHF). The purpose of this study is to understand the current state of the literature with regard to the biomechanical testing of proximal humerus fracture implants. METHODS: A scoping review of the proximal humerus fracture literature was performed, and studies testing the mechanical properties of a PHF treatment were included in this review. Descriptive statistics were used to summarize the characteristics and methods of the included studies. RESULTS: 1,051 proximal humerus fracture studies were reviewed; 67 studies met our inclusion criteria. The most common specimen used was cadaver bone (87%), followed by sawbones (7%) and animal bones (4%). A two-part fracture pattern was tested most frequently (68%), followed by three-part (23%), and four-part (8%). Implants tested included locking plates (52%), intramedullary devices (25%), and non-locking plates (25%). Hemi-arthroplasty was tested in 5 studies (7%), with no studies using reverse total shoulder arthroplasty (RTSA) implants. Torque was the most common mode of force applied (51%), followed by axial loading (45%), and cantilever bending (34%). Substantial testing diversity was observed across all studies. CONCLUSIONS: The biomechanical literature was found to be both diverse and heterogeneous. More complex fracture patterns and RTSA implants have not been adequately tested. These gaps in the current literature will need to be addressed to ensure that future biomechanical research is clinically relevant and capable of improving the outcomes of challenging proximal humerus fracture patterns.

Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Exploratory Health-Related Quality of Life and Patient-Reported Functional Outcomes of a Multi-Centre 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients.

PURPOSE: Femoral neck fractures in young patients are typically managed with internal fixation using either cancellous screws or a sliding hip screw (SHS). Although fixation preserves the hip joint, patients are still at risk of complications and poor clinical outcomes which lead to diminished function and health related quality of life (HRQL). The Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) pilot randomized controlled factorial trial evaluated the effect of surgical fixation (cancellous screws vs. SHS) and vitamin D supplementation vs. placebo on patient-reported function and HRQL. METHODS: Patients between the ages of 18-60 years with a femoral neck fracture requiring surgical fixation were eligible. Eligible patients were randomized to receive either a sliding hip screw or cancellous screws for fracture fixation AND vitamin D3 4,000 IU or placebo daily for 6 months. Patient-reported function (Hip Outcome Score) and HRQL (Short Form-12) were assessed at standardized time points in the 12 months following their fixation surgery. Patient-reported function and HRQL were summarized using means, SD, and 95% confidence intervals (CIs), or percentages and counts. Longitudinal data analysis with mixed models was used to explore the effect of treatment group and time on the patient-reported function and HRQL. RESULTS: 86 of the 91 patients randomized into the FAITH-2 pilot study were deemed eligible. There were no significant differences in patient-reported function or HRQL between the treatment groups at 12 months post-fracture. At the 6- and 9-month assessments, a potential benefit in hip function was seen in the cancellous screw group. In all treatment groups, participants reported lower function and HRQL at 12 months post-fracture as compared to their pre-injury assessment. CONCLUSIONS: Few differences were found in function and HRQL among the treatment groups in the FAITH-2 pilot study. Despite modern implants and vitamin D supplementation, neither function nor HRQL returns to baseline in this population. Additional efforts to improve the outcomes of these challenging injuries are still needed. LEVEL OF EVIDENCE: Therapeutic Level II.

Fixation Using Alternative Implants for the Treatment of Hip Fractures (FAITH-2): The Clinical Outcomes of a Multicenter 2 × 2 Factorial Randomized Controlled Pilot Trial in Young Femoral Neck Fracture Patients.

OBJECTIVE: To assess whether the fixation method and vitamin D supplementation affect the risk of patient-important outcomes within 12 months of injury in nongeriatric femoral neck fracture patients. DESIGN: A pilot factorial randomized controlled trial. SETTING: Fifteen North American clinical sites. PARTICIPANTS: Ninety-one adults 18-60 years of age with a femoral neck fracture requiring surgical fixation. INTERVENTION: Participants were randomized to a surgical intervention (sliding hip screw or cancellous screws) and a vitamin D intervention (vitamin D3 4000 IU daily vs. placebo for 6 months). MAIN OUTCOME MEASUREMENTS: The primary clinical outcome was a composite of patient-important complications (reoperation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion). Secondary outcomes included fracture-healing complications and radiographic fracture healing. RESULTS: Eighty-six participants with a mean age of 41 years were included. We found no statistically significant difference in the risk of patient-important outcomes between the surgical treatment arms (hazard ratio 0.90, 95% confidence interval 0.40-2.02, P = 0.80) and vitamin D supplementation treatment arms (hazard ratio 0.96, 95% confidence interval 0.42-2.18, P = 0.92). CONCLUSIONS: These pilot trial results continue to describe the results of current fixation implants, inform the challenges of improving outcomes in this fracture population, and may guide future vitamin D trials to improve healing outcomes in young fracture populations. Although the pilot trial was not adequately powered to detect treatment effects, publishing these results may facilitate future meta-analyses on this topic. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Cluster identification, selection, and description in cluster randomized crossover trials: the PREP-IT trials.

BACKGROUND: In cluster randomized crossover (CRXO) trials, groups of participants (i.e., clusters) are randomly allocated to receive a sequence of interventions over time (i.e., cluster periods). CRXO trials are becoming more comment when they are feasible, as they require fewer clusters than parallel group cluster randomized trials. However, CRXO trials have not been frequently used in orthopedic fracture trials and represent a novel methodological application within the field. To disseminate the early knowledge gained from our experience initiating two cluster randomized crossover trials, we describe our process for the identification and selection of the orthopedic practices (i.e., clusters) participating in the PREP-IT program and present data to describe their key characteristics. METHODS: The PREP-IT program comprises two ongoing pragmatic cluster randomized crossover trials (Aqueous-PREP and PREPARE) which compare the effect of iodophor versus chlorhexidine solutions on surgical site infection and unplanned fracture-related reoperations in patients undergoing operative fracture management. We describe the process we used to identify and select orthopedic practices (clusters) for the PREP-IT trials, along with their characteristics. RESULTS: We identified 58 potential orthopedic practices for inclusion in the PREP-IT trials. After screening each practice for eligibility, we selected 30 practices for participation and randomized each to a sequence of interventions (15 for Aqueous-PREP and 20 for PREPARE). The majority of orthopedic practices included in the Aqueous-PREP and PREPARE trials were situated in level I trauma centers (100% and 87%, respectively). Orthopedic practices in the Aqueous-PREP trial operatively treated a median of 149 open fracture patients per year, included a median of 11 orthopedic surgeons, and had access to a median of 5 infection preventionists. Orthopedic practices in the PREPARE trial treated a median of 142 open fracture and 1090 closed fracture patients per year, included a median of 7.5 orthopedic surgeons, and had access to a median of 6 infection preventionists. CONCLUSIONS: The PREP-IT trials provide an example of how to follow the reporting standards for cluster randomized crossover trials by providing a clear definition of the cluster unit, a thorough description of the cluster identification and selection process, and sufficient description of key cluster characteristics. TRIAL REGISTRATION: Both trials are registered at ClinicalTrials.gov (A-PREP: NCT03385304 December 28, 2017, and PREPARE: NCT03523962 May 14, 2018).

Fixation Using Alternative Implants for the Treatment of Hip Fractures: The feasibility of a multicenter 2 × 2 factorial randomized controlled trial evaluating surgical treatment and vitamin D supplementation in young femoral neck fracture patients.

OBJECTIVES: To conduct a pilot trial for the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH-2) protocol to assess feasibility of a definitive trial. DESIGN: Pilot trial. SETTING: Twenty-five clinical sites across North America and Australia were initiated, but enrolment occurred in only 15 North American sites. PATIENTS/PARTICIPANTS: Ninety-one randomized adults aged 18 to 60 years with a femoral neck fracture requiring surgical fixation. INTERVENTION: Eligible patients were randomized to receive surgical treatment (sliding hip screw or cancellous screws) AND nutritional supplementation (4000 IU of vitamin D or placebo) for 6 months postfracture. MAIN OUTCOME MEASUREMENTS: Feasibility outcomes included: clinical site initiation, participant enrolment rate, proportion of participants with complete 12-month follow-up, level of data quality, and rate of protocol adherence (number of randomization errors, crossovers between treatment groups, and daily supplementation adherence). RESULTS: Eighty-six of 91 participants randomized into the pilot trial from 15 North American hospitals were deemed eligible. Four of five primary feasibility criteria were not achieved as we were unable to initiate clinical sites outside of North America and Australia due to feasibility constraints, slow participant enrolment (60 participants recruited over 36 mo), low adherence with daily nutritional supplementation at the 6-week (72.1%), 3-month (60.5%), and 6-month (54.7%) follow-up visits, and a high loss to follow-up rate of 22.1% at 12 months. CONCLUSIONS: Despite not meeting key feasibility criteria, we increased our knowledge on the logistics and anticipated barriers when conducting vitamin D supplementation trials in this trauma population, which can be used to inform the design and conduct of future trials on this topic.

Correction to: Cluster identification, selection, and description in Cluster randomized crossover trials: the PREP-IT trials.

An amendment to this paper has been published and can be accessed via the original article.

Effectiveness of Iodophor vs Chlorhexidine Solutions for Surgical Site Infections and Unplanned Reoperations for Patients Who Underwent Fracture Repair: The PREP-IT Master Protocol.

Importance: The risk of developing a surgical site infection after extremity fracture repair is nearly 5 times greater than in most elective orthopedic surgical procedures. For all surgical procedures, it is standard practice to prepare the operative site with an antiseptic solution; however, there is limited evidence to guide the choice of solution used for orthopedic fracture repair. Objective: To compare the effectiveness of iodophor vs chlorhexidine solutions to reduce surgical site infections and unplanned fracture-related reoperations for patients who underwent fracture repair. Design, Setting, and Participants: The PREP-IT (Program of Randomized Trials to Evaluate Pre-operative Antiseptic Skin Solutions in Orthopaedic Trauma) master protocol will be followed to conduct 2 multicenter pragmatic cluster randomized crossover trials, Aqueous-PREP (Pragmatic Randomized Trial Evaluating Pre-Operative Aqueous Antiseptic Skin Solution in Open Fractures) and PREPARE (Pragmatic Randomized Trial Evaluating Pre-Operative Alcohol Skin Solutions in Fractured Extremities). The Aqueous-PREP trial will compare 4% aqueous chlorhexidine vs 10% povidone-iodine for patients with open extremity fractures. The PREPARE trial will compare 2% chlorhexidine in 70% isopropyl alcohol vs 0.7% iodine povacrylex in 74% isopropyl alcohol for patients with open extremity fractures and patients with closed lower extremity or pelvic fractures. Both trials will share key aspects of study design and trial infrastructure. The studies will follow a pragmatic cluster randomized crossover design with alternating treatment periods of approximately 2 months. The primary outcome will be surgical site infection and the secondary outcome will be unplanned fracture-related reoperations within 12 months. The Aqueous-PREP trial will enroll a minimum of 1540 patients with open extremity fractures from at least 12 hospitals; PREPARE will enroll a minimum of 1540 patients with open extremity fractures and 6280 patients with closed lower extremity and pelvic fractures from at least 18 hospitals. The primary analyses will adhere to the intention-to-treat principle and account for potential between-cluster and between-period variability. The patient-centered design, implementation, and dissemination of results are guided by a multidisciplinary team that includes 3 patients and other relevant stakeholders. Discussion: The PREP-IT master protocol increases efficiency through shared trial infrastructure and study design components. Because prophylactic skin antisepsis is used prior to all surgical procedures and the application, cost, and availability of all study solutions are similar, the results of the PREP-IT trials are poised to inform clinical guidelines and bring about an immediate change in clinical practice. Trial Registration: ClinicalTrials.gov Identifiers: NCT03385304 and NCT03523962.

Knowledge Dissemination of Intimate Partner Violence Intervention Studies Measured Using Alternative Metrics: Results From a Scoping Review.

Alternative metrics measure the number of online mentions that an academic paper receives, including mentions in social media and online news outlets. It is important to monitor and measure dispersion of intimate partner violence (IPV) victim intervention research so that we can improve our knowledge translation and exchange (KTE) processes improving utilization of study findings. The objective of this study is to describe the dissemination of published IPV victim intervention studies and to explore which study characteristics are associated with a greater number of alternative metric mentions and conventional citations. As part of a larger scoping review, we conducted a literature search to identify IPV intervention studies. Outcomes included znumber of alternative metric mentions and conventional citations. Fifty-nine studies were included in this study. The median number of alternative metric mentions was six, and the median number of conventional citations was two. Forty-one percent of the studies (24/59) had no alternative metric mentions, and 27% (16/59) had no conventional citations. Longer time since publication was significantly associated with a greater number of mentions and citations, as were systematic reviews and randomized controlled trial designs. The majority of IPV studies receive little to no online attention or citations in academic journals, indicating a need for the field to focus on implementing strong knowledge dissemination plans. The papers receiving the most alternative metric mentions and conventional citations were also the more rigorous study designs, indicating a need to focus on study quality. We recommend using alternative metrics in conjunction with conventional metrics to evaluate the full dissemination of IPV research.

Fixation using alternative implants for the treatment of hip fractures (FAITH-2): design and rationale for a pilot multi-centre 2 × 2 factorial randomized controlled trial in young femoral neck fracture patients.

BACKGROUND: Femoral neck fractures in patients ≤ 60 years of age are often very different injuries compared to low-energy, hip fractures in elderly patients and are difficult to manage because of inherent problems associated with high-energy trauma mechanisms and increased functional demands for recovery. Internal fixation, with multiple cancellous screws or a sliding hip screw (SHS), is the most common treatment for this injury in young patients. However, there is no clinical consensus regarding which surgical technique is optimal. Additionally, there is compelling rationale to use vitamin D supplementation to nutritionally optimize bone healing in young patients. This pilot trial will determine feasibility and provide preliminary clinical data for a larger definitive trial. METHODS: We will conduct a multicenter, concealed randomized controlled pilot study, using a 2 × 2 factorial design in 60 patients aged 18-60 years with a femoral neck fracture. Eligible patients will be randomized in equal proportions to one of four groups: 1) SHS and vitamin D supplementation (4000 international units (IU) daily dose) for 6 months, 2) cancellous screws and vitamin D supplementation (4000 IU daily dose) for 6 months, 3) SHS and placebo, and 4) cancellous screws and placebo. Participants will be followed for 12 months post-fracture. Feasibility outcomes include initiation of clinical sites, recruitment, follow-up, data quality, and protocol adherence. Clinical outcomes, for both the pilot and planned definitive trials, include a composite of patient-important outcomes (re-operation, femoral head osteonecrosis, severe femoral neck malunion, and nonunion), health-related quality of life and patient-reported function, fracture healing complications, and radiographic fracture healing. A priori success criteria have been established. If the pilot study is deemed successful, study participants will be included in the definitive trial and clinical outcomes for the pilot will not be analyzed. If the pilot study is not deemed successful, clinical outcome data will be analyzed. DISCUSSION: Results of this study will inform the feasibility of a definitive trial. If clinical outcome data are analyzed, they will be disseminated through a publication and presentations. TRIAL REGISTRATION: The FAITH-2 trial, described as a definitive trial, was registered at ClinicalTrials.gov (NCT01908751) prior to enrollment of the first participant.

Factors Associated With Health-Related Quality of Life in Patients With Open Fractures.

OBJECTIVES: To analyze FLOW data to identify baseline patient, injury, fracture, and treatment factors associated with lower health-related quality of life (HRQoL) at 12-month postfracture. DESIGN: Prognostic study using data from a prospective randomized controlled trial. SETTING: Thirty-one clinical centers in the United States, Canada, Australia, and India. PATIENTS/PARTICIPANTS: One thousand four hundred twenty-seven patients with open fracture from the FLOW trial with complete 12-month Short Form-12 (SF-12) follow-up assessment and no missing data for selected baseline factors. INTERVENTION: Not applicable. MAIN OUTCOME MEASUREMENT: Physical Component Score (PCS) and the Mental Component Score (MCS) of the SF-12 at 12-month postfracture. RESULTS: One thousand four hundred twenty-seven patients were included in the SF-12 PCS and MCS linear regression models. Smoking, lower preinjury SF-12 PCS and MCS, and work-related injuries were significantly associated with lower SF-12 PCS and MCS at 12-month postfracture. A lower extremity fracture and a wound that was not closed at initial irrigation and debridement were significantly associated with lower 12-month SF-12 PCS but not MCS. Only the adjusted mean difference for lower extremity fractures approached the minimally important difference for the SF-12 PCS. CONCLUSIONS: We identified a number of statistically significant baseline factors associated with lower HRQoL; however, only the presence of a lower extremity fracture approached clinical significance. More research is needed to quantify the impact of these factors on patients and to determine whether changes to modifiable factors at baseline will lead to clinically significant improvements in HRQoL after open fractures. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Outcome Measures for Evaluating Intimate Partner Violence Programs Within Clinical Settings: A Systematic Review of the Literature.

BACKGROUND: Multiple intimate partner violence (IPV) identification and assistance programs have been implemented across clinical settings. The results of these studies are inconclusive and frequently conflicting, resulting in clinical uncertainty and controversy regarding the merits of IPV identification and assistance programs. We aimed to describe the choice of outcome measures used in previously published randomized trials of IPV identification and assistance programs. METHOD: A comprehensive literature search was conducted in the Medline, Embase, PyscInfo, and CENTRAL databases. The outcomes assessed in each included study were extracted and categorized, and the methodological quality of each eligible study was assessed using the Cochrane Risk of Bias tool. RESULTS: Of 20 eligible studies, 6 evaluated IPV identification programs and 14 studies examined IPV assistance programs. The included studies used 48 different outcomes that we classified into 10 categories. For identification studies, the most commonly used outcome categories were IPV disclosure (66.7%) and resource use (66.7%). The most commonly used outcome categories for the IPV assistance studies included IPV recurrence and severity (64.3%) and health outcomes (50%). The included studies demonstrated a number of methodological limitations as identified by the Cochrane Risk of Bias instrument. CONCLUSIONS: IPV identification and assistance programs are evaluated using many different outcome measures. Although this diversity enriches the IPV literature, it makes it challenging to compare studies. The results of this review highlight the challenges of conducting research in the field of IPV and the complexity of selecting, measuring, and interpreting outcomes.

A scoping review of intimate partner violence assistance programmes within health care settings.

Background: The lifetime prevalence of intimate partner violence (IPV) for women presenting to health care settings is estimated to be 38-59%. With the goal of providing help to victims of abuse, numerous IPV assistance programmes have been developed and evaluated across multiple health care settings. Objective: Our scoping review provides an overview of this literature to identify key areas for potential evidence-based recommendations and to focus research priorities. Methods: We conducted a search of MEDLINE, Embase, Cumulative Index of Nursing and Allied Health Literature, Cochrane Database of Systematic Reviews, Cochrane Central Register of Controlled Trials, and psycINFO. We used broad eligibility criteria to identify studies that evaluated the effectiveness of IPV assistance programmes delivered within health care settings. We completed all screening and data extraction independently and in duplicate. We used descriptive statistics to summarize all data. Results: Forty-three studies met all eligibility criteria and were included in our scoping review. Nine categories of assistance programmes were identified: counselling/advocacy, safety assessment/planning, referral, providing IPV resources, home visitation, case management, videos, provider cueing, and system changes. Characteristics of programmes amongst studies frequently reporting positive results included those in which one type of active assistance was used (77.8% of studies reported positive results), a counsellor, community worker, or case manager provided the intervention (83.3% of studies reported positive results), and programmes that were delivered over more than five sessions (100.0% of studies reported positive results). Conclusions: IPV assistance programmes are heterogeneous with regards to the types of assistance they include and how they are delivered and evaluated. This heterogeneity creates challenges in identifying which IPV assistance programmes, and which aspects of these programmes, are effective. However, it appears that many different types of IPV assistance programmes can have positive impacts on women.

Predicting and Preventing Loss to Follow-up of Adult Trauma Patients in Randomized Controlled Trials: An Example from the FLOW Trial.

BACKGROUND: High loss-to-follow-up rates are a risk in even the most rigorously designed randomized controlled trials (RCTs). Consequently, predicting and preventing loss to follow-up are important methodological considerations. We hypothesized that certain baseline characteristics are associated with a greater likelihood of patients being lost to follow-up. Our primary objective was to determine which baseline characteristics are associated with loss to follow-up within 12 months after an open fracture in adult patients participating in the Fluid Lavage of Open Wounds (FLOW) trial. We also present strategies to reduce loss to follow-up in trauma trials. METHODS: Data for this study were derived from the FLOW trial, a funded trial in which payments to clinical sites were tied to participant retention. We conducted a binary logistic regression analysis with loss to follow-up as the dependent variable to determine participant characteristics associated with a higher risk of loss to follow-up. RESULTS: Complete data were available for 2,381 of 2,447 participants. One hundred and sixty-three participants (6.7%) were lost to follow-up. Participants who received treatment in the U.S. were more likely to be lost to follow-up than those who received treatment in other countries (odds ratio [OR] = 3.56, 95% confidence interval [CI]: 2.46 to 5.17, p < 0.001). Male sex (OR = 1.75, 95% CI: 1.15 to 2.67, p = 0.009), current smoking (OR = 1.82, 95% CI: 1.28 to 2.58, p = 0.001), high-risk alcohol consumption (OR = 1.88, 95% CI: 1.16 to 3.05, p = 0.010), and an age of <30 years (OR = 2.16, 95% CI: 1.19 to 3.95, p = 0.012) all significantly increased the odds of a patient being lost to follow-up. Conversely, participants who had sustained polytrauma (OR = 0.52, 95% CI: 0.37 to 0.73, p < 0.001) or had a Gustilo-Anderson type-IIIA, B, or C fracture (OR = 0.60, 95% CI: 0.38 to 0.94, p = 0.024) had lower odds of being lost to follow-up. CONCLUSIONS: Using a number of strategies, we were able to reduce the loss-to-follow-up rate to <7%. Males, current smokers, young participants, participants who consumed a high-risk amount of alcohol, and participants in the U.S. were more likely to be lost to follow-up even after these strategies had been employed; therefore, additional strategies should be developed to target these high-risk participants. CLINICAL RELEVANCE: This study highlights an important need to develop additional strategies to minimize loss to follow-up, including targeted participant-retention strategies. Male sex, an age of <30 years, current smoking, high-risk alcohol consumption, and treatment in a developed country with a predominantly privately funded health-care system increased the likelihood of participants being lost to follow-up. Therefore, strategies should be targeted to these participants. Use of the planning and prevention strategies outlined in the current study can minimize loss to follow-up in orthopaedic trials.

Prevalence of Intimate Partner Violence Among South Asian Women Living in Southern Ontario.

Intimate partner violence (IPV) affects 4 in 10 women in North America in their lifetime and 13-27 % in the past year. The basis for estimates stems largely from studies involving Caucasian women. Less is known about other minority populations such as South Asian women. This study aimed to assess the prevalence of IPV in the past year among South Asian women living in Southern Ontario. We conducted a survey of South Asian women living in Southern Ontario. All adult self-identified South Asian women attending a cultural event celebrating South Asian women who could understand English or Punjabi were eligible to participate. The survey contained three IPV prevalence questions adapted from the Woman Abuse Screening Tool. A total of 188 women (45 % of potentially eligible women) participated. Nearly 1 in 5 women reported IPV within the past year (19.3 %, 95 % CI 13.9-26.1 %). In this study single women were significantly more likely to have experienced IPV in the past year compared to married women (p = 0.035). Self-identified immigrant and non-immigrant South Asian women in this sample of women living in Southern Ontario experienced violence in proportions comparable to the general population. Programs for women should ensure accessibility and support of all ethnicities given equivalent rates of violence in the community.

Prescription of Vitamin D to Fracture Patients: A Lack of Consensus and Evidence.

OBJECTIVES: We conducted a survey to explore practice patterns regarding the assessment of hypovitaminosis D and the prescription of vitamin D in acute fracture patients. Our secondary objective was to determine whether practice patterns differed between fragility and nonfragility fracture patients. DESIGN: Cross-sectional survey. SETTING: All surveys were completed using SurveyMonkey. PATIENTS/PARTICIPANTS: We surveyed surgeon members of the Canadian Orthopaedic Association and the Orthopaedic Trauma Association. INTERVENTION: Survey. MAIN OUTCOME MEASUREMENTS: The proportion of surgeons who routinely prescribe vitamin D to fracture patients. RESULTS: A total of 397 surveys were completed. Of total, 65.8% of surgeons indicated that they routinely prescribe vitamin D to fragility fracture patients and 25.7% routinely prescribe vitamin D to nonfragility fracture patients. We identified considerable variability in dosing regimens, as 45 different dosing regimens were prescribed in fragility fracture patients and 29 in nonfragility fracture patients. They ranged from daily doses of 400 IU to loading doses of 600,000 IU. The most frequently prescribed doses were 1000 IU daily (14.6%), 2000 IU daily (13.4%), and 50,000 IU weekly (8.7%). Respondents indicated that they heavily relied on clinical experience to guide their decisions to prescribe vitamin D to fracture patients. CONCLUSIONS: The results of this survey demonstrate multiple areas of uncertainty and a lack of consensus in the prescription of vitamin D to fracture patients. Fragility patients frequently receive vitamin D supplementation, whereas most surgeons do not prescribe vitamin D to young fracture patients. High-quality clinical research is needed to determine whether vitamin D supplementation is beneficial to fracture patients. LEVEL OF EVIDENCE: Therapeutic Level V. See Instructions for Authors for a complete description of levels of evidence.